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Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients. (MiBioPain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05932433
Recruitment Status : Completed
First Posted : July 6, 2023
Last Update Posted : July 6, 2023
Sponsor:
Information provided by (Responsible Party):
María Elena González Álvarez, Universidad Rey Juan Carlos

Study Description
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Brief Summary:

This study aims to evaluate the effect of therapeutic exercise on the gut microbiome in chronic widespread pain patients. Our investigation purpose is to improve the quality of life of participants, reduce their disability and optimize their functionality.

The intervention will last 6 weeks, with 2 face-to-face therapeutic exercise sessions guided by a professional and a 6-week post-intervention follow-up.

The participation will require:

  1. Attend the 12 therapeutic exercise sessions
  2. Attend the 3 evaluations: at the beginning (A0), post intervention (A1) and +6 weeks after finishing the exercise program (A3).

The items to be evaluated will be the following:

  1. The Ronald Morris Disability Questionnaire (RMDQ)
  2. Anxiety (State-Trait Anxiety Inventory (STAI))
  3. Depression: Beck Depression Inventory (BDI)
  4. Quality of Life: SF-12
  5. Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI)
  6. Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM)
  7. Perform a pre blood test on interleukins IL-18 and IL-1β

This study involves the processing of personal data, so the researchers will guarantee confidentiality in their treatment at all times, complying with the personal data protection regulations, in particular, European Regulation 679/2016. , of April 27, general data protection, as well as Organic Law 3/2018, of December 5, Protection of Personal Data and Guarantee of Digital Rights.

In order to maintain your privacy and anonymity during the research, only one person on the research team will know how names were assigned to a participation number.


Condition or disease Intervention/treatment Phase
Arthritis Fibromyalgia Arthritis Rheumatoid Artrosis of the Knee Chronic Pain Central Sensitisation Gut Microbiota Exercise Therapy Behavioral: Exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
Actual Study Start Date : May 1, 2023
Actual Primary Completion Date : June 1, 2023
Actual Study Completion Date : June 10, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise
Exercise during 6 weeks, twice a week.
 Behavioral: Exercise
Each session (45 minutes aprox) is made by: mobility, endurance and final exercise to rest. The sesion is going to perform twice a week during 6 weeks.
Other Names:
  • Therapeutic exercise
  • physical activity
No Intervention: Control
There is no intervention


Outcome Measures
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Primary Outcome Measures :
  1. Quantitative Sensory Test (QST), and [ Time Frame: From enrollment to the end of the intervention at 6 weeks ]
    Conditioned Pain Modulation (CPM) and pain threshold will be assesed as measured of QST.

  2. Psychological and PainTest [ Time Frame: From enrollment to the end of the intervention at 6 weeks ]
    Furthermore,Beck Depression Inventory and State-Trait Anxiety Inventory (STAI) will be perform as a psychological test. The Brief Pain Inventory (BPI) and a numerical rate scale will be perform as a pain tests.

  3. Descriptive parameters [ Time Frame: From enrollment to the end of the intervention at 6 weeks ]
    Descriptive parameters of the sample will be explain in a table


Secondary Outcome Measures :
  1. Interleukin analysis [ Time Frame: From enrollment to the end of the intervention at 6 weeks ]
    Interleukin-18 and interleukin-1β analysis will be perform in tha baseline in control group and at the end of the intervention in the experimental (exercise) group


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be at least 18 years old
  • Must be diagnosed with: osteoarthritis, osteoarthritis, Sudeck or fibromyalgia.

Exclusion Criteria:

  • Suffering or having suffered from cancer, psychiatric disorders, or another ongoing major illness (irritable bowel syndrome, hepatitis, Lyme disease or diabetes).
  • Patients will be excluded if they have more than 6 points on the Beck Depression Inventory, more than 30 points on the "State Trait Anxiety Inventory" or suffer from dementia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05932433


Locations
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Spain
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain, 28922
Sponsors and Collaborators
Universidad Rey Juan Carlos
Investigators
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Study Director: Jorge H Jorge Hugo Villafañe, Dr. Responsable científico, Centro "S. Maria ai Colli" - Presidio Ospedaliero "Ausiliatrice", Torino, de la Fondazione Don Carlo Gnocchi Onlus, Italia.
More Information
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Responsible Party: María Elena González Álvarez, Principal Investigator, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT05932433    
Other Study ID Numbers: 1601202303523
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: July 6, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data and its interpretation are going to be publicated in the Scientific Community through specific and scientific Journals about this topic and Congress.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Fibromyalgia
Arthritis, Rheumatoid
Chronic Pain
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
 Muscular Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases